A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine

February 11, 2025 updated by: Sinocelltech Ltd.

A Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (SCTV02) in Healthy Adults ≥18 Years of Age

This is a randomised, double-blind, placebo-controlled Phase 1/2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Three dose-levels of SCTV02 will be evaluated in participants aged 18 years and older. Solicited adverse events within 7 days post study vaccination and unsolicited adverse events within 30 days post study vaccination will be collected. Immunogenicity including Neutralizing antibody against RSV-A and RSV-B will be tested 14, 30, 90, 180 and 365 days post study vaccination will be assessed. T cell response will be tested 30 days post study vaccination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hebei
      • Langfang, Hebei, China, 965000
        • Recruiting
        • Hebei Zhongshiyou Central Hospital
        • Contact:
          • Zhao Kexin, Doctor
          • Phone Number: 86-0316-2073657
    • Sichuan
      • Luzhou, Sichuan, China, 646399
        • Not yet recruiting
        • Luzhou Center for Disease Control and Prevention
        • Contact:
          • He Wenlin, Doctor
          • Phone Number: 86-0830-2584041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Phase I: male and female participants ≥18 years old at the time of signing the ICF; Phase II: male and female participants ≥50 years of age at the time of signing the ICF.
  • Be able to sign a written Informed consent form (ICF) and participate in the trial voluntarily, and can fully understand the trial procedures and risks of participating in the trial.
  • Be able to complete the diary card, contact card and diary/contact card by own or with the assistance of others.
  • Phase I: healthy subjects or healthy subjects judged by the investigator according to the clinical data of the subjects; Stage II: Subjects who are healthy or have a stable underlying disease.
  • Fertile men and women of childbearing age voluntarily agree to use effective contraception from the time they sign the ICF until 6 months after immunization; Pregnancy test results for women of childbearing age during the screening period were negative.

Exclusion Criteria:

  • Acute illness and/or fever (axillary temperature ≥37.3 ° C) occurred within 3 days prior to vaccination with the study vaccine, or antipyretic, analgesic, or antiallergic drugs.
  • Use any investigational or unregistered product within 30 days prior to immunization, or plan to use any such product during the study period.
  • Concurrent participation in another clinical study where the subject has been or will be exposed to an investigational or non-investigational vaccine/product at any time during the study.
  • Long-term or high-dose glucocorticoid therapy (duration ≥15 days, or dose ≥1 mg/kg/ day of prednisone or equivalent doses of other glucocorticoids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination.
  • The study received a non-attenuated vaccine within 14 days prior to vaccination, or a live attenuated vaccine within 28 days; Have previously received the experimental respiratory syncytial virus (RSV) vaccine or been infected with RSV within 1 year prior to receiving the investigational vaccine.
  • History or family history of epilepsy and mental illness.
  • A family history of congenital or hereditary immunodeficiency, or a history and physical examination confirmed or suspected immunosuppression or immunodeficiency, or human immunodeficiency virus (HIV) infection, asplenia or functional asplenia.
  • Have the following organ-specific or systemic autoimmune diseases: Guillain-Barre syndrome, myasthenia gravis, autoimmune hepatitis, ulcerative colitis, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, and systemic sclerosis.
  • Allergic to any component of the study vaccine, or any previous history of severe allergy to vaccine vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.
  • Severe chronic disease or active chronic disease, as assessed by the investigator, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, uncontrolled blood pressure after medication (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg in subjects < 60 years of age; Hypertensive disease with systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg in subjects ≥60 years of age, diabetes mellitus with serious complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart diseases, respiratory diseases, liver and kidney diseases, and thyroid diseases.
  • Pregnant women (positive pregnancy test) or breastfeeding women, or those with pregnancy plans during the study period, or less than 6 weeks after the end of pregnancy (including ectopic pregnancy).

Plan to donate eggs or sperm during the study.

  • Unable to follow the trial procedures, or plan to relocate or stay away for a long period of time during the study and cannot complete the trial follow-up.
  • Any medical condition that makes intramuscular injection unsafe due to other abnormalities, conditions that may obfuscate the results of the study, or conditions that are not in the best interest of the subject, is determined by the investigator to be unsuitable for clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A: Low dose vaccine
Low dose of SCTV02, injected on Day 0
Biological: SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
Placebo Comparator: A: Low dose placebo
Placebo comparator of low dose, injected on Day 0
Biological: Placebo
Participants will receive a singe dose of Placebo on Day 0.
Experimental: B: Medium dose vaccine
Medium dose of SCTV02, injected on Day 0
Biological: SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
Placebo Comparator: B: Medium dose placebo
Placebo comparator of medium dose, injected on Day 0
Biological: Placebo
Participants will receive a singe dose of Placebo on Day 0.
Experimental: C: High dose vaccine
High dose of SCTV02, injected on Day 0
Biological: SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
Placebo Comparator: C: High dose placebo
Placebo comparator of high dose, injected on Day 0
Biological: Placebo
Participants will receive a singe dose of Placebo on Day 0.
Experimental: D: Low dose vaccine
Low dose of SCTV02, injected on Day 0
Biological: SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
Experimental: E: Medium dose vaccine
Medium dose of SCTV02, injected on Day 0
Biological: SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
Experimental: F: High dose vaccine
High dose of SCTV02, injected on Day 0
Biological: SCTV02
Participants will receive a singe dose of SCTV02 on Day 0.
Placebo Comparator: G: Placebo
Placebo comparator, injected on Day 0
Biological: Placebo
Participants will receive a singe dose of Placebo on Day 0.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of solicited adverse events within 7 days post study vaccination.
Time Frame: Day o to Day 7
Incidence and severity of solicited adverse events within 7 days post study vaccination.
Day o to Day 7
Geometric mean titer (GMT) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 30 days post vaccination
Time Frame: Day 30
Geometric mean titer (GMT, Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 30 days after study vaccination.
Day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
T cell response
Time Frame: Day 30
Number of T cell subsets activated by interferon-γ (for Th1) and interleukin-4 (for Th2) 30 days after study vaccination.
Day 30
GMT of nAb against RSV-A and RSV-B subtypes 14 days after study vaccination.Immunogenicity 14 days post vaccination
Time Frame: Day 14
GMT of nAb against RSV-A and RSV-B subtypes 14 days after study vaccination.
Day 14
GMT of nAb against RSV-A and RSV-B subtypes 90 days post vaccination
Time Frame: Day 90
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 90 days after study vaccination.
Day 90
GMT of nAb against RSV-A and RSV-B subtypes 180 days post vaccination
Time Frame: Day 180
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 180 days after study vaccination.
Day 180
GMT of nAb against RSV-A and RSV-B subtypes 365 days post vaccination
Time Frame: Day 365
GMT (Live Virus Neutralization Test) of neutralizing antibodies (nAb) against RSV-A and RSV-B subtypes 365 days after study vaccination.
Day 365
Incidence and severity of unsolicited adverse events within 30 days
Time Frame: Day to Day 30
Incidence and severity of unsolicited adverse events within 30 days after study vaccination.
Day to Day 30
Incidence and severity of Serious adverse events and adverse events of special interest within 365 days
Time Frame: Day 0 to Day 365
Incidence and severity of Serious adverse events and adverse events of special interest within 365 days after study vaccination.
Day 0 to Day 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinocelltech Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhao Kexin, Doctor, Hebei Zhongshiyou Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCTV02-X201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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